Injector needle insertion retraction assembly

ABSTRACT

A needle insertor for a medicament delivery device is presented having a driver having a first part movably arranged within the case and a second part connected to the base, a needle assembly movably held by the first part in the case, a rotator arranged in the case and configured to engage the first part for moving the driver, an energy accumulation member configured to interact with the rotator for applying a rotational force on the rotator, a movable stop arranged on the base and configured to interact with the rotator for preventing the rotator from rotating. The first part has a first position where the needle assembly is held inside the case, a second position where the needle portion is positioned outside the case after being moved to pass through the injection site end, and a third position where the needle portion is positioned inside the case.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a Divisional of U.S. Application No.15/734,291, filed Dec. 2, 2020, which is a U.S. National PhaseApplication pursuant to 35 U.S.C. §371 of International Application No.PCT/EP2019/074302 filed Sep. 12, 2019, which claims priority to U.S.Provisional Pat. Application No. 62/735,045 filed Sep. 22, 2018, andEuropean Patent Application No. 18205273.8 filed Nov. 8, 2018. Theentire disclosure contents of these applications are herewithincorporated by reference into the present application.

TECHNICAL AREA

The present disclosure relates to a needle insertion and retractionassembly of a medicament delivery device and in particular to a needleinsertion and retraction assembly in which the needle and catheter areinserted at an insertion site and the needle is subsequently withdrawnfrom the insertion site

BACKGROUND

A large number of people suffering from diabetes use some form ofinsulin therapy to maintain close control of their glucose levels.Currently, there are two principal modes of daily insulin therapy. Thefirst mode includes syringes and insulin pens. These devices are simpleto use and are relatively low in cost, but they require a needle stickat each injection, typically three to four times per day. The secondmode includes infusion pump therapy, which entails the purchase of aninsulin pump that lasts for about three years. The initial cost of thepump can be significant, but from a user perspective, the overwhelmingmajority of patients who have used pumps prefer to remain with pumps forthe rest of their lives. Infusion pumps, although more complex thansyringes and pens, offer the advantages of continuous infusion ofinsulin, precision dosing and programmable delivery schedules. Thisresults in closer blood glucose control and an improved feeling ofwellness.

The use of an infusion pump further requires the use of a disposablecomponent, typically referred to as an infusion set or pump set, whichconveys the insulin from a reservoir within the pump into the skin ofthe user. An infusion set typically consists of a pump connector, alength of tubing, and a hub or base from which an infusion needle orcannula extends. The hub or base has an adhesive that retains the baseon the skin during use. The hub or base may be applied to the skinmanually or with the aid of a manual or automatic insertion device.Often, the insertion device is a separate, stand-alone unit that theuser is required to carry and provide.

There are many available versions of infusion sets, including steelcannula infusion sets and soft (flexible) catheter sets. Soft cathetersets are typically inserted into a patient manually with the aid of asteel introducer needle, which is later removed from the patient leavingthe soft catheter in place. In another type of infusion set, as notedabove, a mechanized insertor is used to automatically insert theintroducer needle and catheter, remove the introducer needle, or both.The introducer needle is completely removed from the infusion set beforethe soft catheter is connected to the insulin pump.

One problem associated with manually inserting and retracting theintroducer needle is variability in the insertion and retraction force,speed, smoothness and angle. This variability can lead to an increasedrate of catheter insertion failure.

Further, as noted above, the user typically must remove the introducerneedle after inserting the cannula. This exposes the user to accidentalneedle sticks from handling the removed introducer needle.

Accordingly, a need exists for an infusion set that facilitatesinsertion of the cannula, while reducing the number of components a usermust carry and substantially preventing accidental needle sticks.

SUMMARY

In the present disclosure, when the term “distal” is used, this refersto the direction pointing away from the dose delivery site. When theterm “distal part/end” is used, this refers to the part/end of thedelivery device, or the parts/ends of the members thereof, which underuse of the medicament delivery device is/are located furthest away fromthe dose delivery site. Correspondingly, when the term “proximal” isused, this refers to the direction pointing to the dose delivery site.When the term “proximal part/end” is used, this refers to the part/endof the delivery device, or the parts/ends of the members thereof, whichunder use of the medicament delivery device is/are located closest tothe dose delivery site.

Further, the term “longitudinal”, with or without “axis”, refers to adirection or an axis through the device or components thereof in thedirection of the longest extension of the device or the component.

The term “lateral”, with or without “axis”, refers to a direction or anaxis through the device or components thereof in the direction of thebroadest extension of the device or the component. “Lateral” may alsorefer to a position to the side of a “longitudinally” elongated body.

In a similar manner, the terms “radial” or “transversal”, with orwithout “axis”, refers to a direction or an axis through the device orcomponents thereof in a direction generally perpendicular to thelongitudinal direction, e.g. “radially outward” would refer to adirection pointing away from the longitudinal axis.

Also, if nothing else is stated, in the following description whereinthe mechanical structure of the device and the mechanicalinterconnection of its components is described, the device is in aninitial non-activated or non-operated state.

These and other aspects of, and advantages with, the present disclosurewill become apparent from the following detailed description of thepresent disclosure and from the accompanying drawings.

According to a main aspect of the disclosure it is characterized by aneedle insertor for a medicament delivery device, comprising, a casehaving a base and an injection site end, a driver having a first partmovably arranged within the case and a second part connected to thebase, a needle assembly movably held by the first part of the driver inthe case, a rotator arranged in the case and configured to interact withthe first part of the driver for moving the driver, an energyaccumulation member configured to interact with the rotator for applyinga rotational force on the rotator, a movable stop arranged on the baseand configured to interact with the rotator for preventing the rotatorfrom rotating. The needle assembly includes a needle portion positionedsubstantially perpendicular to the injection site end.

Further, the first part has a first position where the needle assemblyis held inside the case, a second position where the needle portion ispositioned outside the case after being moved to pass through theinjection site end and pierce an injection site, and a third positionwhere the needle portion is positioned inside the case. In addition, amovable stop is further configured to interact with the rotator forreleasing the rotator and allow the rotational force from the energyaccumulation member to rotate the rotator to further allow the firstpart to move between said positions.

In one embodiment, the needle insertor may further comprise a cannulaassembly configured to interact with the needle assembly, wherein thecannula assembly remains within the case when the first part is in thefirst position. The cannula assembly is moved by the needle assembly toenter the injection site when the first part is in the second position.

Further, the cannula assembly includes a cannula base portion and acannula portion substantially perpendicular to the injection site end.The cannula portion is coupled with the cannula base portion andconfigured to enter the injection site when the first part is in thesecond position. The cannula portion is positioned in the injection sitewhen the first part is in the second position.

The cannula base portion includes a medicament input opening, whereinthe cannula portion and cannula base portion are hollow so that amedicament can pass through the medicament input opening, the cannulabase portion, and exits through the cannula portion.

Further, the needle portion is positioned within the cannula portionwhen the first part is in the first and second positions, the needleportion is not positioned within the cannula portion when the first partis in the third position.

The cannula base portion is positioned between the needle assembly andthe injection site end, wherein the needle assembly interacts with thecannula base portion to move the cannula assembly toward the injectionsite end when the first part moves from the first position to the secondposition.

Further, the base includes at least one locking member configured toengage and fix the cannula assembly on the base when the first partreaches the second position.

The base includes a container port for accommodating a medicamentcontainer, a piercer coupled with the container port for piercing themedicament container, a medicament path assembly coupled with the base.The medicament tube assembly having a first end connected to the piercerand a second end connected to the cannula assembly, wherein a medicamentcan flow from the medicament container through the piercer and themedicament tube assembly to enter the cannula assembly.

The needle assembly can further include a needle base portion coupledwith the needle portion and configured to be movably held by the firstpart, wherein the first part of the driver drives the needle baseportion to move the needle portion outside the case when moving from thefirst position to the second position. The first part of driver drivesthe needle base portion to move the needle portion back inside the casewhen moving from the second position to the third position.

The rotator further includes an engagement member configured to interactwith the first part, wherein the engagement member of the rotator isrotated by the energy accumulation member interacts with the first partto move the first part between said positions.

In one embodiment, the second part of the driver is pivotably fixed onthe case. However, in another embodiment, the driver can have a flexibleelastic structure, wherein elasticity of the driver allows the secondpart of the driver to move the first part of the driver to the thirdposition when the engagement member no longer interacts with the firstpart.

The base includes a first rest configured to accommodate the energyaccumulation member and a second rest configured to engage the rotatorand keep the rotator rotatably connected to the base. The injection siteend of the case includes a first injection site opening configured forthe needle assembly to pass through and pierce the injection site. Thebase includes a second injection site opening corresponding to the firstinjection site opening, the needle assembly passes through both thefirst and second injection site openings to pierce the injection site.The base includes a guiding structure forming a channel extendingperpendicularly to the injection site end, wherein the needle assemblyis at least partially accommodated in the channel while held movably bythe first part of the driver.

The needle insertor can further include a sleeve configured toaccommodate the rotator and the energy accumulation member, wherein thebase includes a sleeve port configured to accommodate the sleeve.

BRIEF DESCRIPTION OF DRAWINGS

In the following detailed description of the present disclosure,reference will be made to the accompanying drawings, of which

FIG. 1 shows an exploded view of an example needle insertor according toa first embodiment of the present disclosure.

FIG. 2 shows an exploded view of the insert assembly according to thefirst embodiment of the present disclosure.

FIG. 3 shows an exploded view of cannula assembly and medicament pathassembly according to the first embodiment of the present disclosure.

FIGS. 4A, 4B and 4C show perspective views and exploded views of theneedle assembly, cannula assembly, and medicament path assembly as wellas a perspective view of said components assembled.

FIGS. 5A and 5B show perspective views and exploded views of the torsionspring, rotator, and sleeve as well as a perspective view of saidcomponents assembled.

FIG. 6 shows an exploded view of the base, piercer, cannula assembly,driver, needle assembly, and medicament path assembly.

FIG. 7 shows a perspective view of the base, piercer, driver, needleassembly, cannula assembly, and medicament path assembly assembled.

FIG. 8 shows a perspective view of a movable stop to be assembled withthe base.

FIG. 9 shows a perspective view of a torsion spring, rotator, and sleeveto be assembled with the base.

FIG. 10 shows a cross-section view of the needle insertor before therotator is released.

FIG. 11 shows a cross-section view of the needle insertor when therotator is rotated by an associated torsion spring.

FIG. 12 shows a cross-section view of the needle insertor when therotator retracts the needle portion back inside the case and isprevented from further rotating.

FIG. 13 shows an exploded view of an example needle insertor accordingto a second embodiment of the present disclosure.

FIG. 14 shows a perspective view of the needle insertor according to asecond embodiment of the present disclosure.

FIG. 15 shows another perspective view of the needle insertor accordingto a second embodiment of the present disclosure.

DETAILED DESCRIPTION

FIG. 1 shows an exploded view of a needle insertor 100 according to thefirst embodiment of the present disclosure. The needle insertor 100includes a case 200, a cover 300, a plurality of fixing elements 310, anO-ring 320, a first seal 331, a second seal 332, and a third seal 333.The needle insertor 100 further includes an insertor assembly 500positioned within the enclosure of the case 200 and cover 300. Thestructure of insertor assembly 500 will be further explained in detailsbelow.

The case 200 includes a first opening 211, a second opening 212, and athird opening 213 on an injection site end 240, wherein the injectionsite end 240 faces the injection site when a medicament delivery devicehaving the needle insertor 100 is placed on the injection site. Thefirst, second, and third seals 331, 332, 333 are configured to attach tothe case 200 to cover the first, second, and third openings 211, 212,213.

The insertor assembly 500 includes a container port 501 configured witha piercer 502 for piercing a medicament container. The insertor assembly500 further includes a movable stop 530 (illustrated in FIG. 2 )configured to be moved to activate the needle insertion sequence of theinsertor assembly 500. The insertor assembly 500 includes a fourthopening 214 (illustrated in FIG. 1 ) corresponding to the third opening213, wherein a needle within the insertor assembly 500 will pass throughthe third and fourth openings 213, 214 to penetrate the injection site.When the insertor assembly 500 is positioned inside the case 200, thepiercer 502 and stop 530 will be respectively exposed through the firstand second openings 211, 212 of the case 200. However, the first andsecond seals 331, 332 cover the two openings 211, 212 to ensure thatexternal objects will not interact with the piercer 520 and stop 530before the needle insertor 100 is ready for use. Similarly, the thirdseal 333 covers the third and fourth openings 213, 214 to ensure that noexternal objects interact with the needle within the insertor assembly500 before the needle insertor 100 is ready for use.

The cover 300 is configured to couple with the case 200 and covers theopening through which the insertor assembly 500 is inserted into thecase 200. The cover 300 includes an O-ring portion 301 surrounded by theO-ring 320. This arrangement allows the O-ring portion 301 and O-ring320 to create a seal with the inner surface of case 200 when insertedinto the case 200. In this embodiment, the fixing elements 310 arescrews configured to pass through the corresponding screws openings onthe case 200 and cover 300 to secure the two components 200, 300together. Together, case 200, cover 300, and the first, second, thirdseals 331, 332, 333 ensure that external objects will not make contactwith insertor assembly 500 before the needle insertor 100 is ready foruse. Also, other suitable fixing elements known to a skilled person suchas bolts can be used to secure the case 200 and cover 300 together.

FIG. 2 shows an exploded view of the insertor assembly 500 according tothe first embodiment of the present disclosure. The insertor assembly500 includes a base 510, a piercer 502, a cannula assembly 520, amovable stop 530, a driver 540, a needle assembly 550, a medicament pathassembly 570, an energy accumulation member 580, a rotator 590, and asleeve 600. The function of each component mentioned above and itsrelationship with the base 510 will be explained in more details below.

FIG. 3 shows an exploded view of the cannula assembly 520 and medicamentpath assembly 570. The cannula assembly 520 includes a cannula portion521 and a cannula base portion 522. The cannula portion 521 and cannulabase portion 522 are both hollow inside. The cannula base portion 522has a hose opening 523 and a cannula mount 524 that has an opening toaccommodate the cannula portion 521. The hollow cannula portion 521 ismounted on the cannula mount 524 to gain access to the inner space ofthe cannula base portion 522. Thus, once the cannula portion 521 iscoupled with the cannula mount 524, liquid entering the hose opening 523will be able to pass through the inner space of cannula base portion 522and then exit through the cannula portion 521.

In the present embodiment, the medicament path assembly 570 includes anattachment pin 571, a first crimp 572, a second crimp 573, and a hose574. The attachment pin 571 has a thicker portion configured to befitted in the hose opening 523 to gain access to the inner space ofcannula base portion 522. The attachment pin 571 also has a thinnerportion configured to be coupled with one end of the hose 574, whereinthe first crimp 572 surrounds the portion of hose 574 coupled with theattachment pin 571 to ensure that the two components are fastened. Thesecond crimp 573 is configured to surround the portion of hose 574coupled with the piercer 502 which will be explained with figure later.

In the present embodiment, the medicament path assembly 570 includesfour components assembled together. In other embodiments, the medicamentpath assembly 570 can instead include only one tube or other number ofcomponents suitable to be assembled with the cannula assembly 520.

FIGS. 4B & 4C shows an exploded view of the needle assembly 550 (seeFIG. 4A), cannula assembly 520 (see FIG. 4B), and medicament pathassembly 570 as well as a perspective view of the assembly of saidcomponents. The cannula assembly 520 and medicament path assembly 570are assembled as described above. On the other hand, the needle assembly550 includes a needle base portion 551 and needle portion 552 coupledtogether. The cannula base portion 522 includes a needle opening 525 forallowing access to the inner space of cannula base portion 522. Thus,the needle portion 552 can pass through the needle opening 525 and passthrough the cannula portion 521 as illustrated on the right side of FIG.4A.

In the present embodiment, the cannula base portion 522 includes a basecoupling key 526 having a protrusion 527. On the other hand, the needlebase portion 551 has a coupling trough 553 configured to couple with theprotrusion 527. Said structure ensures that the needle base portion 551and cannula base portion 522 are coupled together in such as a way thatexternal forces will not cause vibration of the needle base portion 551that may cause damage to the needle portion 552 within the cannulaportion 521. The configuration also serves to make sure that the cannulabase portion 522 is coupled with a corresponding needle base portion551. Also, in other embodiments, the protrusion 527 can be disposed onthe needle base portion 551 while the corresponding coupling trough 553is disposed on the base coupling key 526. Other suitable configurationcan also be used to couple the needle base portion 551 with the cannulabase portion 522.

FIG. 5B shows an exploded view of the energy accumulation member 580(see FIG. 5A), rotator 590, and sleeve 600 as well as a perspective viewof the assembly of said components. The rotator 590 has a driver end 591and a coupling end 592 for passing through the energy accumulationmember 580 and coupling with the sleeve 600. The drive end 591 isconfigured to interact with the driver 540 (illustrated in FIG. 2 ) whenthe rotator 590 is released to be rotated by the energy accumulationmember 580. The sleeve 600 is hollow in order to accommodate both theenergy accumulation member 580 and the rotator 590. The sleeve 600 has arotator coupling opening 601 configured to allow the coupling end 592 topass through and couple with the sleeve 600. Each of the two couplingends 592 has a fin 593 extending and slanting radially outward. When thecoupling end 592 is pressed against the inner surface of sleeve 600, theinner surface of sleeve 600 forces the slanting surface of fin 593 andcoupling end 592 as a whole to flex radially inward. In this way, boththe coupling ends 592 together become thin enough to pass through therotator coupling opening 601. Afterward, the coupling ends 592 flexradially outward and the fins 593 engage the outer surface of sleeve 600surrounding the opening 601 to prevent the rotator 590 from being pulledaway. This coupling allows the rotator 590 to be rotatable relative tothe sleeve 600 and prevents the rotator 590 to move longitudinallyrelative to the sleeve 600. On the other hand, the energy accumulationmember 580 has two ends, one positioned between the two coupling ends592 of rotator 590 and the other positioned in a notch 602 on the sleeve600.

In the present embodiment, the energy accumulation member 580 is atorsion spring. However, in other embodiments, the energy accumulationmember 580 can be other forms of force generating component capable ofaccumulating energy and release the energy when released.

FIG. 6 shows an exploded view of the base 510, piercer 502, cannulaassembly 520, driver 540, needle assembly 550, and medicament pathassembly 570. FIGS. 7 and 8 show perspective views of the assembly ofpiercer 502, base 510, cannula assembly 520, driver 540, needle assembly550, and medicament path assembly 570. The base 510 has a container port511 for accommodating a medicament container and a piercer opening 512for accommodating the piercer 502. In the present embodiment, the end ofhose 574 surrounded by the second crimp 573 is positioned on one end ofthe piercer opening 512 while the piercer 512 passes through the otherend of piercer opening 512 to be coupled with both the base 510 and hose574. Thus, a medicament container can have its seal pierced to have themedicament within flowing through the piercer 502, hose 574, cannulabase portion 522, and finally exit through the cannula portion 521.

In the present embodiment, the base 510 has a guiding structure 513configured to accommodate and guide the insertion of the needle assembly550 and cannula assembly 520. The guiding structure 513 creates a spacewith size and shape corresponding to those of the needle assembly 550and cannula assembly 520. As illustrated in FIG. 8 , the base 510 hasthe fourth opening 214 configured for the cannula portion 521 and needleportion 552 to pass through and reach the injection site.

As illustrated in FIGS. 6 and 7 , the base 510 also has a driver rest514 configured to couple with the driver 540. In the present embodiment,the driver 540 has a first part 541 configured to couple with the needlebase portion 551, a second part 542, and a third part 543 configured tocouple with the driver rest 514. As illustrated, the third part 543 ofdriver 540 has a circular opening with size corresponding to that of thedriver rest 514. Thus, the base 510 and driver 540 can be coupled byputting the third part 543 on the driver rest 514 as illustrated in FIG.7 .

Further, as illustrated in FIG. 6 , the needle base portion 551 has adriver opening 554 configured for the first part 541 of driver 540 topass through to couple the driver 540 with the needle assembly 550. Whenthe first part 541 is under no external forces it maintain the positionof the needle assembly 550 on one end of guiding structure 513 away fromthe injection site opening 514, as illustrated in FIGS. 7 and 8 . On theother hand, external forces may also be exerted on the first part 541 tomove the needle assembly 550 toward the injection site opening 514 aswill be explained later.

Here please refer to FIG. 8 for the explanation on installation of themovable stop 530. In the present embodiment, the base 510 has a stoprest 515 configured to accommodate the movable stop 530. The stop 530has a main portion 531 and a first obstruction portion 532. On the otherhand, the stop rest 515 is tubular and has a tunnel 516 for the mainportion 531 to pass through and a gap 517 for the first obstructionportion 532 to pass through. One end of the tunnel 516 is disposed withstop openings 518 so that an external object can move the stop 530 byinteracting with the main portion 531 through the stop openings 518.

Here please refer to both FIGS. 9 and 10 for the installation of theenergy accumulation member 580, rotator 590, and sleeve 600 as well asthe interaction between the stop 530 and rotator 590. In the presentembodiment, the base 510 has a sleeve port 517 configured to accommodatethe assembly of the energy accumulation member 580, rotator 590, andsleeve 600. The sleeve port 517 includes a second obstruction portion519 disposed on the inner surface of the sleeve port 517. As illustratedin FIGS. 2 and 10 , the rotator 590 includes a driving member 591configured to interact with the first part 541 of driver 540 after therotator 590 is released. Also as illustrated in FIG. 10 , the rotator590 also has an engagement member 592 configured to interact the firstobstruction portion 532 of stop 530 before the rotator 590 is released.The engagement member 592 is also configured to interact with the secondobstruction portion 519 after the rotator 590 is released. Theinteraction between components mentioned above will be explained in moredetails below.

When the assembly of the energy accumulation member 580, rotator 590,and sleeve 600 is inserted in the sleeve port 517 of base 510, theengagement member 592 of rotator 590 will be positioned between thegap/space between the obstruction portion 518 of sleeve port 517 and thefirst obstruction portion 532 of stop 530. See FIG. 10 . In the presentembodiment illustrated in FIG. 10 , the energy accumulation member 580constantly applies a rotational force on the rotator 590 in a clockwisedirection. However, the first obstruction portion 532 prevents suchclockwise rotation of the rotator 590 by engaging the engagement member592. Unless the stop 530 is moved in order for the first obstructionportion 532 to disengage the engagement member 592, the energyaccumulation member 580 will not be able to rotate the rotator 590 in aclockwise direction.

FIG. 11 shows a cross-section view of the needle insertor 100 after thestop 530 disengaged the rotator 590. An external object can be used topush the stop 530 exposed through the stop openings 518 of base 510. SeeFIG. 12 . The result of the stop’s 530 movement is that its firstobstruction portion 532 is no longer in engagement with the engagementmember 592 of rotator 590. Thus, the rotator 590 is promptly rotatedunder the rotational force of the energy accumulation member 580 in aclockwise direction. During such rotation, the driving member 591interacts with the first part 541 of driver 540 and pushes the firstpart 541 downward toward the injection site end 240. As mentioned above,the first part 541 is coupled with the needle base portion 551 of needleassembly 550. Also, the needle base portion 551 is positioned above thecannula base portion 522 of cannula assembly 520. Thus, as the firstpart 541 is pushed downward, the first part 541 will also push both thecannula assembly 520 and needle assembly 550 downward. This downwardmovement results in both the needle portion 552 passing through thethird opening 213 of case 200 and fourth opening 214 on the base 510 topierce the injection site to create an opening. Similarly, the cannulaportion 521 also passes through the injection site opening 514 andenters the injection site through the opening created by the needleportion 552. The needle penetration and cannula insertion procedures arecomplete.

FIG. 12 shows a cross-section view of the needle insertor 100 after therotator 590 is prevented from further rotating by the second obstructionportion 519 of sleeve port 517. As mentioned above, the energyaccumulation member 580 constantly applies rotational forces on therotator 590, even after the needle penetration and cannula insertionprocedures have been accomplished. The rotator 590 eventually rotates tothe point where its engagement member 592 engages the second obstructionmember 519 and the energy accumulation member 580 can no longer rotatethe rotator 590. See FIG. 12 . At this moment, the driving member 591 isno longer in engagement with the first part 541. Thus, the resilientnature of the driver 540 allows the first part 541 to move upward. Sincethe first part 541 is coupled with the needle base portion 551, thismovement also brings the needle assembly 550 as a whole upward.

On the other hand, the base 510 has a pair of locking members 610disposed on its inner surface next to the injection site opening 514. Inthe present embodiment, the locking members 610 each have the shape of ahook. When the cannula assembly 520 is pushed toward the injection siteopening 514, its cannula base portion 522 will push the locking members610 radially outward in order to reach the inner surface of base 510. Asthe cannula base portion 522 reaches the inner surface of base 510, thelocking members flex radially inward and then engage the cut-outs on theouter surface of cannula base portion 522. The hook shape of lockingmembers 610 ensures that the cannula assembly 520 will not be broughtback up together with the needle base portion 551 by the first part 541.Accordingly, the cannula assembly 520 and needle assembly 550 willseparate when the first part 541 returns to its initial position. Theneedle retraction and cannula locking procedures are complete.

Now that the needle retraction and cannula locking procedures arecomplete, the needle portion 552 no longer occupies the space in thecannula portion 521. Thus, after a medicament container is inserted inthe container port 501 to have its seal pierced by the piercer 502, themedicament within can flow through the piercer 502, hose 574, cannulabase portion 522, cannula portion 521, and eventually enter theinjection site.

FIG. 13 shows an exploded view of an example needle insertor 10according to a second embodiment of the present disclosure. The needleinsertor 10 includes a case 20, a driver arm 30, a needle assembly 40, acannula assembly 50, a rotator 60, a torsion spring 70, a stop member80, and a connection member 90, wherein the rotator 60 includes a firstrotator 61 and a second rotator 62. The second rotator 62 is madetransparent to facilitate illustration.

On the other hand, FIG. 14 shows a perspective view of the needleinsertor 10 according to the second embodiment of the presentdisclosure. The case 20 is made transparent to facilitate theillustration. The case 20 includes a base 21 to accommodate the rest ofthe needle insertor 10, a driver arm portion 22 for coupling with oneend of the driver arm 30, a guide structure 23 for accommodating theneedle assembly 40 and the cannula assembly 50 and guiding the movementthereof, a first rotator stand 24 for accommodating the first rotator61, a second rotator stand 25 for accommodating the second rotator 62,and a stop member stand 26 for accommodating the stop member 80. Thebase 21 includes a needle opening 27 for the needle assembly 40 andcannula assembly 50 to pass through and exits outside the case 20. Thebase 21 also includes a locking member 28 for later fixing the cannulaassembly 50 on the base 21. The case 20 also includes an activationmember opening 29 configured for an activation member (not illustrated)to pass through and interact with the stop member 80 and then releasethe rotator 60. The interaction between the elements on the case 20 withthe rest of the needle insertor 10 will be further explained later.

In the present embodiment, the torsion spring 70 is accommodated in thespace (illustrated in FIG. 13 ) carved out of the first rotator 61 andconstantly exerts a rotational force on the first rotator 61. The firstrotator 61 and torsion spring 70 are both placed on the first rotatorstand 24.

As illustrated in FIG. 13 , the stop member 80 has a first protrusion 81configured to be inserted into the opening of the stop member stand 26(illustrated in FIG. 14 ) in order to couple the stop member 80 with thebase 21. However, the first protrusion 81 is not fixed within the stopmember stand 26 and the stop member 80 is rotatable with respect to theaxis of the stop member stand 26. The stop member 80 has a secondprotrusion 82 configured to couple with the first rotator 61 in order toprevent the rotator 60 as a whole from being rotated by the torsionspring 70. As illustrated in FIG. 13 , the first rotator 61 includes astop groove 63 configured to accommodate the second protrusion 82. Asdescribed above, the torsion spring 70 constantly applies rotationalforce on the first rotator 60. The second protrusion 82 can absorb therotational force and prevent the first rotator 60 from rotating. Thestop member 80 also has a third protrusion 83 configured to be pushed inorder to rotate the second protrusion 82 in either a clockwise oranticlockwise direction. The purpose of the third protrusion 83 is to berotated by user to subsequently rotate the second protrusion 82 out ofthe stop groove 63 in order to release the first rotator 61. Asdescribed above, the case 20 also includes an activation member opening29 configured for an activation member (not illustrated) to passthrough. The activation member can push the third protrusion 83 torotate the second protrusion 82 out of the stop groove 63 so that therotator 60 can be released and then rotated by the torsion spring 70.

The case 20 includes a container port 91 with a piercer opening 92 canbe fitted with a piercer similar to the piercer 502 in the firstembodiment. A medicament container can be inserted in the container port91 to have its seal pierced so that the medicament within can flowthrough the piercer to reach the interior of case.

The first rotator 61 and second rotator 62 are meant to be coupledtogether so that the rotational force of the torsion spring 70 canrotate both rotators 61, 62 simultaneously. The first rotator 61 has arotator opening 66 and the second rotator 62 has a corresponding rotatorprotrusion 67 configured to be fitted into the rotator opening 66. Theshape of both the rotator opening 66 and rotator protrusion 67 are notcircular so that the rotational force from the torsion spring 70 can betransferred from the first rotator 61 to the rotator protrusion 64 andthen the second rotator 62 as a whole.

In the present embodiment, one first portion 31 of the driver arm 30 isrotatably coupled with the driver arm portion 22 of the case 20. Thefirst portion 31 has an opening configured to be aligned with the twoopenings of the driver arm portion 22. The connection member 90 is thenfitted in the space of the three openings in order to couple the driverarm 30 with the driver arm portion 22. Also, the connection member 90,opening of the first portion 31, and opening of the corresponding driverarm portion 22 preferably have circular shapes or other suitable shapein order for the first portion 31 to be rotatably coupled with thedriver arm portion 22.

The driver arm 30 further includes a cam opening 32 and the secondrotator 62 includes a cam 65 configured to be fitted within the camopening 32. As described above, the rotational force from the torsionspring 70 rotates both the first rotator 61 and second rotator 62. Thecam 65 fitted inside the opening 32 allows the second rotator 62 todirectly interact with the driver arm 30. In this way, the rotationalforce can be transferred from the cam 65 to the driver arm 30. However,since the first portion 31 is coupled with the base 21 of the case 20,the rotational force from the cam 65 allows the cam 65 to travel withinthe cam opening 32 and will only pivot the driver arm 30 upward anddownward. Thus, as long as the torsion spring 70 keeps the rotator 60rotating, the driver arm 30 will continuously be pivoted upward anddownward.

The introducer needle 40 includes a needle portion 41 and a needle baseportion 42 located at one end of the needle portion 41. On the otherhand, the driver arm 30 has a second portion 33 configured to grip thebase portion 42. As the driver arm 30 is pivoted downward by therotational force from the rotator 60, the second portion 33 will drivethe base portion 42 as well as needle assembly 40 as a whole downwardtoward the base 20 so that the needle portion 41 can pass through theneedle opening 27 on the base 21 to initiate needle penetration.

The cannula 50 includes a cannula portion 51 and a cannula base portion52 located at one end of the cannula portion 51. The cannula baseportion 52 has a first opening 53 that allows the needle portion 41 ofthe introducer needle 40 to pass through. The cannula portion 51 ishollow inside and the space inside the cannula portion 51 is connectedto the first opening 53 of the cannula base portion 52. Also, the needleportion 41 is longer than the cannula portion 51. Thus, the needleportion 41 of the needle assembly 40 can go all the way through thecannula portion 51 so that its sharp end can emerge outside the cannulaportion 51. See FIG. 15 . As the needle portion 41 pass through thecannula portion 51, the base portion 42 of the needle assembly 40 willabut the cannula base portion 52 of the cannula 50. Afterwards, theforce moving the needle assembly 40 will be transferred to the cannulaassembly 50 and move the needle assembly 40 and cannula assembly 50together downward toward the base 21. Also, as illustrated in FIG. 14 ,the guide structure 23 is configured to accommodate the shape of thebase portion 52 of the cannula 50. The guide structure 23 has gapscorresponding to the three protrusions on the cannula base portion 52.Thus, each of the protrusions is only allowed to move with thecorresponding gap. The shape of the central passage of the guidestructure 23 also corresponds in shape to that of the cannula baseportion 52. The reason for the guide structure 23 to have shapescorresponding to those of the base portion 52 is to ensure that theneedle assembly 40 and cannula assembly 50 remain at least substantiallyperpendicular to the base 21 at all times. Also, the cannula baseportion 52 includes a second opening (not illustrated) configured to beconnected with a medicament tube for medicament to pass through. Thesecond opening is connected to the cannula portion 51. Thus, themedicament passing through the second opening can enter the cannula baseportion 52, the cannula portion 51, and eventually the injector site.

As mentioned above, the container port 91 with a piercer allows amedicament container to be inserted to have its seal pierced so that themedicament within can flow through the piercer to reach the inside ofcase. A tube can be used to connect with the piercer and the secondopening of cannula base portion 52. In this way, medicament within thecontainer can flow through the piercer, tube, cannula base portion 52,and cannula portion 51 to eventually enter the injection site.

Initially, the second protrusion 82 of the stop member 80 is located inthe stop groove 63 of the first rotator 61 to absorbs the torsionspring’s forces and prevent the rotator 60 from rotating. Until thesecond protrusion 82 moves out of the stop groove 63, nothing willhappen.

Then, an activation member passes through the activation opening 29 ofthe case 20 to push the third protrusion 83 and rotate the secondprotrusion 82 out of the stop groove 63. The moment the secondprotrusion 82 leaves the stop groove 63, the forces of the torsionspring 70 will force the first rotator 61 and the second rotator 62 tostart rotating. As the second rotator 62 rotates, cam 65 of the secondrotator 62 located inside the cam opening 32 will transfer the forces tothe driver arm 30 to press the driver arm 30 downward toward the base21. Also, since the first portion 31 of the driver arm 30 is fixed onthe driver arm portion 22 of the case 20, the driver arm 30 as a wholewill be pivoted relative to the driver arm portion 22. The forces on thesecond portion 33 are transferred to base portion 42 of the needleassembly 40 and subsequently the cannula base portion 52 of the cannulaassembly 50. The forces moves both the needle assembly 40 and cannula 50downward toward the base 21 and the two components are maintainedperpendicular to the base 20 due the guidance of the guide structure 23surrounding the two components.

The needle portion 41 of the needle assembly 40 will pass through theneedle opening 27 on the base 21 to create an opening by piercing aninjector site which is typically the user’s skin. The cannula portion 51then follows the needle portion 41 and enters the injection site.Further, when the cannula base portion 52 of the cannula 50 reaches itslower position, it will substantially make contact with the base 21. Thelocking member 28 on the base 21 will couple with the cannula baseportion 52 to fix the cannula base portion 52 on the base 21 and thecannula portion 51 at least partly within the injector site.

The locking member 28 of the present embodiment is similar to thelocking member 610 in the previous embodiment and has the shape of ahook. When the cannula assembly 50 is pushed toward the base 21, itscannula base portion 52 will push the locking members 28 outward inorder to reach the base 21. As the cannula base portion 52 reaches thebase 21, the locking members 28 returns to their initial positions andrespectively engages the cannula base portion 52. The hook shape oflocking members 28 ensures that the cannula assembly 50 will not bebrought back up later with the needle assembly 40 by the driver arm 30.In other words, the cannula assembly 50 and needle assembly 40 willseparate when driver arm 30 returns to its initial position.

After the needle portion 41 passes through the needle opening 27 on thebase 21, the torsion spring 70 continues to rotate the rotator 60 andthe cam 65 of the second rotator 62 can continue to pivot the driver arm30. Afterward, the forces from the torsion spring 70 will force the cam65 within the cam opening 32 to pivot the driver arm 30 upward and awayfrom the base 21. Since the second portion 33 of the driver arm 30 iscoupled with the base portion 42 of the needle assembly 40, the driverarm 30 will retract the needle assembly 40 back into the case 20.

During this movement, the needle portion 41 is pulled out of theinjection site and passes through the space within the cannula 50 tocreate a clear passage from the second opening of the base portion 52 tothe opening of the cannula portion 51. In this way, the medicament canthen flow through the second opening 55 and exit the cannula portion 51in order to enter the injection site for medicament injection. At thisstage, the needle insertor 10 has accomplished its purpose of creatingan opening on the injection site using the needle assembly 40, insertingthe cannula 50 into the injection site, and retracting the needleassembly 40 back into the case 20 in order to create a passage formedicament to flow through the cannula 50 and enter the injection site.

In the Figures, various engagement features for are shown for providingan engagement between one or more components of the drug deliverydevice. The engagement features may be any suitable connecting mechanismsuch as a snap lock, a snap fit, form fit, a bayonet, lure lock, threadsor combination of these designs. Other designs are possible as well.

It should be understood that the illustrated components are intended asan example only. In other example embodiments, fewer components,additional components, and/or alternative components are possible aswell. Further, it should be understood that the above described andshown embodiments of the present disclosure are to be regarded asnon-limiting examples and that they can be modified within the scope ofthe claims.

While various aspects and embodiments have been disclosed herein, otheraspects and embodiments will be apparent to those skilled in the art.The various aspects and embodiments disclosed herein are for purposes ofillustration and are not intended to be limiting, with the true scopebeing indicated by the following claims, along with the full scope ofequivalents to which such claims are entitled. It is also to beunderstood that the terminology used herein is for the purpose ofdescribing particular embodiments only, and is not intended to belimiting.

1. A needle insertor assembly for a medicament delivery device,comprising: a case having a base comprising a needle opening and adriver arm portion; a driver having a first part rotatably coupled tothe driver arm portion, a cam opening and a second part extendingoutward from the cam opening; a needle assembly comprising a baseportion and a needle portion positioned substantially perpendicular tothe needle opening; a rotator having an axis of rotation arranged in thecase and configured to interact with the first part of the driver formoving the driver; an energy accumulation member configured to interactwith the rotator for applying a rotational force on the rotator; and amovable stop that engages with the rotator to prevent the rotator fromrotating; wherein the second part of the driver is engaged with the baseportion of the needle assembly in a first position prior to rotation ofthe rotavator such that the needle assembly is held inside the casewherein rotation of the rotator causes the second part to move to asecond position where the needle portion is positioned outside the caseafter being moved to pass through the needle opening to pierce aninjection site wherein further rotation of the rotator moves the secondpart to a third position where the needle portion is retracted toposition inside the case, and wherein a rotational movement of themovable stop relative to the base and along an axial path that isperpendicular to the axis of rotation of the rotator disengages themovable stop from the rotator to allow the rotational force from theenergy accumulation member to rotate the rotator along the axis ofrotation causing the second part to move from the first position to thesecond position and to the third positions.
 2. The needle insertorassembly of claim 1 further comprising a cannula assembly operativelyassociated with a guide structure position on the base.
 3. The needleinsertor assembly of claim 2, wherein the cannula assembly comprises: acannula base portion; and a cannula portion substantially perpendicularto the needle opening and configured to enter the injection site as thesecond part moves from the first position to the second position suchthat the cannula portion is positioned in the injection site before thesecond part moves to the third position.
 4. The needle insertor assemblyof claim 3, wherein the cannula base portion includes a medicament inputopening, the cannula portion and cannula base portion are hollow so thata medicament can pass through the medicament input opening, the cannulabase portion, and exits through the cannula portion.
 5. The needleinsertor assembly of claim 3, wherein the cannula base portion ispositioned between the base portion of the needle assembly and theneedle opening such that the needle assembly interacts with the cannulabase portion to move the cannula assembly toward the needle opening whenthe second part moves from the first position to the second position. 6.The needle insertor assembly of claim 1, wherein the movable stopcomprises a first protrusion rotatably positioned on the base and asecond protrusion configured to movably disengage from the rotator. 7.The needle insertor assembly of claim 1, wherein the movable stopcomprises a third protrusion that when rotated relative to the base willcause a second protrusion configured to movably disengage from therotator.
 8. The needle insertor assembly of claim 1, wherein the movablestop comprises a protrusion rotatably movable from a first positionengaged with the rotator to prevent rotation of the rotator to a secondposition disengaged from rotator to cause rotation of the rotator andmovement of the second part of the driver from the first position to thesecond position.
 9. The needle insertor assembly of claim 1, wherein thecase further comprises an activation opening that provides access to themoveable stop.
 10. The needle insertor assembly of claim 1, wherein therotator comprises a first rotator and a second rotator.
 11. The needleinsertor assembly of claim 10, wherein the energy accumulation memberrotates both the first rotator and the second rotator when the movablestop disengages from the rotator.
 12. The needle insertor assembly ofclaim 10, wherein the second rotator has a cam.
 13. The needle insertorassembly of claim 12, wherein the cam is engaged with the cam openingsuch that rotation of the rotator cause the driver to pivotally moverelative to the driver arm portion.
 14. The needle insertor of claim 10,wherein the base further comprises: a first rotator stand configured toaccommodate the energy accumulation member and the first rotator; and asecond rotator stand configured to configured to accommodate the secondrotator.
 15. The needle insertor assembly of claim 2 further comprisinga locking member that fixes the cannula assembly to the base structurebefore the second part of the driver moves to the third position. 16.The needle insertor assembly of claim 1, wherein the needle portion ispositioned within the cannula portion when the second part is in thefirst and second positions and the needle portion is not positionedwithin the cannula portion when the second part is in the thirdposition.
 17. The needle insertor assembly of claim 3, wherein thecannula base portion is positioned between the needle assembly and theinjection site end, the needle assembly interacts with the cannula baseportion to move the cannula assembly toward the injection site end whenthe first part moves from the first position to the second position. 18.The needle insertor of claim 1, wherein the base further comprises: acontainer port for accommodating a medicament container; a piercercoupled with the container port for piercing the medicament container; amedicament path assembly coupled with the base, the medicament pathassembly having a first end connected to the piercer and a second endconnected to the cannula assembly; wherein a medicament can flow fromthe medicament container through the piercer and the medicament tubeassembly to enter the cannula assembly.
 19. A medicament delivery devicecomprising: the needle insertor assembly as claimed in claim 1; and acontainer port comprising a piercer positioned perpendicular to theneedle portion.
 20. A needle insertor assembly for a medicament deliverydevice, comprising: a case having a base comprising a needle opening anda driver arm portion; a driver having a first part pivotally coupled tothe driver arm portion, a cam opening and a second part extendingoutward from the cam opening; a needle assembly comprising a baseportion engaged with the second part and a needle portion positionedsubstantially perpendicular to the needle opening; a first rotatoroperatively and a second rotator and sharing a common axis of rotation,where the second rotator comprises a cam slidably engaged in the camopening such that rotation of the first and second rotators causesmovement of the driver; an energy accumulation member configured tointeract with the first rotator for applying a rotational force to boththe first and the second rotators; and a rotatable stop comprising afirst protrusion, a second protrusion and a third protrusion, where thesecond protrusion engages with the first rotator to prevent the rotatorsfrom rotating; wherein the second part of the driver comprises a slotthat is slidably engaged with the base portion of the needle assembly ina first position prior to rotation of the rotavator such that the needleassembly is held inside the case wherein rotation of the first rotatorcauses the second part to move to a second position where the needleportion is positioned outside the case after being moved to pass throughthe needle opening to pierce an injection site wherein further rotationof the first rotator moves the second part to a third position where theneedle portion is retracted to position inside the case, and wherein arotational movement of the third protrusion of the movable stop aboutthe first protrusion relative to the base disengages the secondprotrusion from the first rotator to allow the rotational force from theenergy accumulation member to rotate the rotators along the axis ofrotation causing the second part to move from the first to the secondpositions.